Table 6. Prospective randomized phase III studies of first-generation EGFR TKIs in untreated patients with advanced EGFR mutation-positive NSCLC.
Study | Population | Treatment arms | No. of pts | RR (%) | Median PFS | Median OS | |||
---|---|---|---|---|---|---|---|---|---|
Months | HR; P | Months | HR; P | ||||||
IPASS | East Asian | Gefitinib | 609 [132]* | 43.0 (71.2) | 9.5 | 0.48; <0.001 | 21.6 | 1.0; 0.99 | |
Adeno & nonsmokers | Carbo/pacli | 608 [129]* | 32.2 (47.3) | 6.3 | 21.9 | ||||
First- | Korean | Gefitinib | 159 [26]* | 55.4 (84.6) | 8.4 | 0.544; 0.086 | 22.3 | 0.932; 0.60 | |
SIGNAL | Adeno & nonsmokers | Cis/gem | 150 [16]* | 46.0 (37.5) | 6.7 | 22.9 | |||
WJTOG3405 | Japanese | Gefitinib | 86 | 62.1 | 9.2 | 0.489; <0.0001 | 35.5 | 1.2; 0.44 | |
EGFR mut | Cis/doce | 86 | 32.2 | 6.3 | 38.8 | ||||
NEJ002 | Japanese | Gefitinib | 114 | 73.7 | 10.8 | 0.30; <0.001 | 27.7 | 0.88; 0.48 | |
EGFR mut | Carbo/pacli | 114 | 30.7 | 5.4 | 26.6 | ||||
OPTIMAL | Chinese | Erlotinib | 82 | 83 | 13.1 | 0.16; <0.0001 | 22.8 | 1.19; 0.26 | |
EGFR mut | Carbo/gem | 72 | 36 | 4.6 | 27.2 | ||||
EURTAC | European | Erlotinib | 86 | 64 | 9.7 | 0.37; <0.0001 | 19.3 | 1.04; 0.87 | |
EGFR mut | Platinum CT | 87 | 18 | 5.2 | 19.5 | ||||
ENSURE | Asian | Erlotinib | 110 | 62.7 | 11 | 0.34; <0.0001 | 26.3 | 0.91; 0.61 | |
EGFR mut | Cis/gem | 107 | 33.6 | 5.5 | 25.5 |
*, patients with confirmed EGFR mut. EGFR, epidermal growth factor receptor; TKIs, tyrosine-kinase inhibitors; NSCLC, non-small cell lung cancer.